McDaniel v. Upsher-Smith Labs., Inc.

Citation893 F.3d 941
Decision Date29 June 2018
Docket NumberNo. 17-5741,17-5741
Parties Rita MCDANIEL, Individually and as Personal Representative of the Estate of Johnny F. McDaniel, Deceased, Plaintiff–Appellant, v. UPSHER–SMITH LABORATORIES, INC., Defendant–Appellee.
CourtUnited States Courts of Appeals. United States Court of Appeals (6th Circuit)

ARGUED: Samuel C. Cole, COLE, EASLEY, SCIBA & WILLIAMS, Victoria, Texas, for Appellant. Mark C. Hegarty, SHOOK, HARDY & BACON LLP, Kansas City, Missouri, for Appellee. ON BRIEF: E. Kirk Wood, Jr., WOOD LAW FIRM, LLC, Birmingham, Alabama, for Appellant. Eric E. Hudson, Kyle R. Cummins, BUTLER SNOW LLP, Memphis, Tennessee, for Appellee.

Before: COLE, Chief Judge; SILER and COOK, Circuit Judges.

COOK, J., delivered the opinion of the court in which SILER, J., joined, and COLE, C.J., joined in part. COLE, C.J. (pp. 948–51), delivered a separate opinion concurring in part and dissenting from Part II.B. of the majority opinion.

COOK, Circuit Judge.

Rita McDaniel’s husband died after taking a course of a prescription drug manufactured by Upsher–Smith Laboratories, Inc. She sued, alleging that Upsher–Smith’s failure to ensure that a Medication Guide accompanied the prescription led to her husband ingesting—and dying because of—a drug that wasn’t meant for him. We are tasked with deciding whether the Federal Food, Drug, and Cosmetic Act ("FDCA") impliedly preempts McDaniel’s Tennessee failure-to-warn claims premised solely on Upsher–Smith’s failure to provide the Medication Guide as required by FDA regulations. It does. We AFFIRM.


We take as true the well-pleaded allegations in McDaniel’s complaint and summarize them as follows. See Stein v. HHGREGG, Inc. , 873 F.3d 523, 528 (6th Cir. 2017).

Upsher–Smith manufactures a generic form of the prescription drug amiodarone

hydrochloride ("amiodarone"). The FDA approved amiodarone in its brand-name formulation as a drug of last resort for patients suffering from ventricular fibrillation and ventricular tachycardia, both life-threatening heartbeat irregularities.

As a generic manufacturer of amiodarone, Upsher–Smith has an ongoing duty to ensure that it includes the same labeling approved for its brand-name counterpart. See 21 U.S.C. § 355(j)(2)(A)(v). One of those labeling requirements is to make "Medication Guides" available for distribution to each patient with each prescription, by providing them—or the means to produce them—to distributors, packers, or authorized dispensers of the drug. 21 C.F.R. § 208.24(b). Medication Guides explain the approved uses of a drug and its side effects to a patient "in nontechnical, understandable language" that is clearly presented in at least 10–point font. See id. § 208.20.

The Medication Guide for amiodarone

warns patients that the drug "should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias." Lung damage is listed as a "serious side effect" of taking the drug, along with related symptoms such as shortness of breath and wheezing. Because "the medicine stays in your body for months after treatment is stopped," these adverse effects may continue even after ceasing treatment.


Rita McDaniel, Johnny’s widow, sued Upsher–Smith on behalf of her late husband’s estate. In general, she alleges that her husband died in July 2015 because he had been taking amiodarone

. More specifically, Johnny’s doctor prescribed him a course of amiodarone to treat his non-life threatening atrial fibrillation. Johnny apparently did not receive the corresponding Medication Guide when he filled his prescriptions in May and June 2015 because Upsher–Smith neglected to ensure its availability. Thus, he was unaware that only adults with life-threatening heartbeat problems who had unsuccessfully sought alternative treatments should take the drug.

McDaniel sued on multiple theories, but only her Tennessee strict-liability failure-to-warn, negligent failure-to-warn, and negligence-per-se claims are before us. The failure-to-warn claims are premised solely on Upsher–Smith’s failure to provide a Medication Guide. Upsher–Smith moved to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). The district court granted Upsher–Smith’s motion and dismissed the failure-to-warn claims with prejudice, holding that they were impliedly preempted under the FDCA. The court explained that McDaniel failed to cite any Tennessee duty paralleling the federal duty to provide a Medication Guide. Said differently, the claims would not exist in the absence of the FDCA.


We review de novo the district court’s dismissal on federal preemption grounds. Fulgenzi v. PLIVA, Inc. , 711 F.3d 578, 583 (6th Cir. 2013).

When state and federal laws clash, federal law reigns supreme and state law is preempted. U.S. Const., art. VI, cl. 2. "State-law claims can be preempted expressly in a federal statute or regulation, or impliedly, where congressional intent to preempt state law is inferred." Yates v. Ortho–McNeil–Janssen Pharm., Inc. , 808 F.3d 281, 293 (6th Cir. 2015). In the absence of an express preemption statute, as here, federal law may impliedly preempt state law to the extent the two laws conflict. Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta , 458 U.S. 141, 153, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982). This type of implied preemption, known as conflict preemption, comes in two forms—impossibility and obstacle preemption. State Farm Bank v. Reardon , 539 F.3d 336, 342 (6th Cir. 2008). Impossibility preemption exists when compliance with both federal and state law is impossible. Gade v. Nat’l Solid Wastes Mgmt. Ass’n , 505 U.S. 88, 98, 112 S.Ct. 2374, 120 L.Ed.2d 73 (1992) ; Florida Lime & Avocado Growers, Inc. v. Paul , 373 U.S. 132, 142–43, 83 S.Ct. 1210, 10 L.Ed.2d 248 (1963). Obstacle preemption exists when state law serves as an obstacle to the purposes and objectives embodied in a federal law. Gade , 505 U.S. at 98, 112 S.Ct. 2374 ; Hines v. Davidowitz , 312 U.S. 52, 67, 61 S.Ct. 399, 85 L.Ed. 581 (1941).


McDaniel’s failure-to-warn claims based on Upsher–Smith’s alleged failure to provide a Medication Guide are impliedly preempted. Except in circumstances not relevant here, "all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States." 21 U.S.C. § 337(a). "The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance ...." Buckman Co. v. Plaintiffs’ Legal Comm. , 531 U.S. 341, 349 n.4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001).

In alleging a failure to warn, McDaniel does not "rely[ ] on traditional state tort law which had predated the federal enactments in question[ ]. On the contrary, the existence of these federal enactments is a critical element in [her] case." Id. at 353, 121 S.Ct. 1012. McDaniel seeks to enforce the federal regulation requiring drug manufacturers to ensure the availability of Medication Guides for distribution to patients. See 21 C.F.R. § 208.24. Her complaint makes this eminently clear. For instance, she asserts:

The failure to provide each patient a "Medication Guide" by failing to provide the Medication Guides to the distributor for ultimate distribution to the patient with the drug is a direct violation of the FDA’s mandate to the manufacturers of the drug intended to warn patients directly outside the communication with the prescribing physician, of the very dangers of amiodarone

toxicity that injured Johnny McDaniel.

Other parts of the complaint similarly demonstrate that the existence of the Medication Guide regulation is a "critical element" in McDaniel’s suit. Here are just a few:

The Defendant manufacturer, Upsher–Smith, was responsible by federal regulation for ensuring that the appropriate warning labels and Medication Guides were provided to McDaniel. Had the Medication Guide been provided by Upsher–Smith to the distributor or his pharmacists for distribution to him as required by FDA regulations, McDaniel ... would not have taken amiodarone


• Because his distributors and pharmacists were not provided a Medication Guide to give directly to him outside of his doctor’s office and interaction as required by FDA regulations by the Defendant manufacturer, McDaniel did not know "the medicine stays in your body for months after treatment is stopped."

• McDaniel did not receive a Medication Guide because the Defendant Upsher–Smith did not provide the Medication Guide to the distributors for distribution to him by his pharmacists as required by the FDA and did not ensure that the Medication Guide was distributed to McDaniel.

McDaniel’s opposition to Upsher–Smith’s motion to dismiss further underscores that this litigation is strictly about Upsher–Smith’s compliance with federal regulations that are enforceable only by the Federal Government. She insisted that her "failure-to-warn claims [are] based on Upsher–Smith’s failure to provide the FDA required Medication Guide to Johnny" and that "[t]he Medication Guide that Johnny did not receive was required by federal law to be provided to" him. What’s more, McDaniel explicitly disclaimed the argument that her failure-to-warn claims stem from inadequate content. She described her complaint as alleging that Upsher–Smith "failed to actually and physically provide for the appropriate distribution of federally mandated warnings in the form of the Medication Guide." Then she doubled down on her reliance on the FDA’s regulations: "The allegation is not one of adequacy or ‘content’ failure to warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of Upsher–Smith to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients with each prescription."

McDaniel cannot salvage her appeal by hanging her hat on a generic duty to warn under Tennessee law. Cf. Loreto v....

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